By Jeffrey H. Brochin, J.D.
Prior FDA reviews that mandated in-person requirements for mifepristone were deemed outdated and of limited value given the present-day ability to use telemedicine to counsel patients.
A federal district court in Maryland has granted the motion for preliminary injunction filed by the American College of Obstetricians and Gynecologists (ACOG) and other interested reproductive health organizations that challenged the enforcement of certain FDA requirements relating to in-person dispensing and signature requirements for an oral medication used to induce an abortion or to manage a miscarriage. The court found that in light of the convergence of numerous factors stemming from the COVID-19 pandemic, the in-person requirements imposed a substantial obstacle to abortion or miscarriage patients seeking care, and that the undue burden standard was met (American College of Obstetricians and Gynecologists v. FDA, July 13, 2020, Chuang, T.).
Approvals of medication abortion drug. In September 2000, the FDA approved Mifeprex®, the brand name for the drug mifepristone, as the first non-surgical abortion drug approved for the early termination of an intrauterine pregnancy. The drug is also used to manage a miscarriage in order to reduce the need for an in-office procedure. The agency recognized that the drug carried serious risks, such as an incomplete abortion or serious bleeding. In an effort to mitigate potential complications, the FDA put in place several restrictions on dispensing and distributing the drug, including that the drug be prescribed only by a qualified physician and that it be administered in a hospital, clinic, or medical office only by or under the supervision of such a physician.
In 2007, the FDA deemed the imposed restrictions to be an approved Risk Evaluation and Mitigation Strategy (REMS), a statutorily authorized designation which allows for additional FDA restrictions beyond those set forth on the drug’s labeling. The federal government can enforce REMS against healthcare providers. In 2011, the FDA approved the existing mifepristone REMS with additional Elements to Assure Safe Use (ETASU), a special category of REMS. An ETASU can be imposed on a drug that has been shown to be effective but is associated with a serious adverse drug experience such that it can be approved only on the condition that the designated elements are satisfied. The ETASU requirements imposed in 2011 mandated that the drug be prescribed only by specially certified physicians, that it be dispensed only in hospitals, clinics, or medical offices, and that it be dispensed only with documentation that certain safe-use conditions were met, such as securing the signature of the patient on a Patient Agreement Form.
2013 and 2016 reviews. In 2013, the FDA reviewed the existing REMS and reaffirmed the elements already in place, and in 2016, in response to a supplemental application by the drug sponsor requesting modifications to the REMS, the FDA conducted another review of the existing mifepristone REMS and determined that no new safety concerns had arisen and that the known serious risks occurred rarely. The agency found that it was likely that serious adverse events would remain acceptably low.
Covid-19 PHE. On March 13, 2020, President Trump issued a proclamation declaring the COVID-19 outbreak in the United States to be a national emergency, and he authorized the Secretary of HHS to temporarily waive or modify certain Medicare, Medicaid, and health insurance requirements for the duration of the public health emergency (PHE). Furthermore, the governors of all 50 states declared a state of emergency or PHE and issued various stay-at-home orders, restrictions on the operation of businesses and restaurants, and limitations on social gatherings in response to the pandemic.
ETASU waivers and telemedicine. In March and April 2020, the FDA informed drug sponsors for two other drugs that during the pandemic it would not enforce the associated ETASU requirement that a drug be administered or dispensed only at a hospital, clinic, or medical office—the same limitation imposed on mifepristone—even though both still needed to be administered in-person by a physician. The FDA also announced that during the PHE, it would not enforce certain REMS ETASU requirements if a health care professional exercising medical judgment determined that the patient could safely forgo such requirements.
Based on his PHE declaration, the Secretary invoked the use of the "telemedicine exception" in the Controlled Substances Act (CSA), which permits practitioners to forgo otherwise mandatory requirements that they conduct an in-person evaluation of a patient before prescribing certain controlled substances, and to permit them instead to rely on telemedicine to assess a patient before issuing a prescription.
Meeting the undue burden standard. It is against the foregoing background that ACOG challenged the ETUSA REMS applicable for the dispensing of mifepristone. They produced evidence as to the economic burdens faced by patients in need of a medical abortion, as well as transportation burdens and the inherent risk of contracting Covid-19 itself. In considering the long list of burdens as well as reviewing several case histories of patients who were burdened because of the existing ETUSA REMS, the court found that in light of the COVID-19 pandemic, the In-Person Requirements caused an undue burden in violation of the Constitution, imposing a substantial obstacle on a large fraction of the relevant women seeking an abortion. They also noted that a burden did not need to be absolute in order to be undue.
Outdated reviews. In response to the FDA’s argument that its prior determinations were entitled to administrative agency deference, the court pointed out that in 2013 and 2016 the FDA did not consider the use of telemedicine in any way, presumably because it was not frequently used at the time. However, because that telemedicine was now in widespread use, it is an effective means of providing counseling relating to medication abortion. Therefore, both the 2013 and 2016 reviews were deemed to be outdated on that point and of only limited value on the salient question of whether the In-Person Requirements remain necessary given the present-day ability to use telemedicine to counsel patients at or near the time the drug is provided.
Based on the foregoing, the court issued a preliminary injunction enjoining the FDA from enforcing, threatening to enforce, or otherwise applying the In-Person Requirements contained in the mifepristone REMS as to medication abortion patients, to extend until the resolution of the case or until 30 days after the end of the PHE declared by the Secretary of HHS.
The case is Civil Action No. TDC-20-1320.
Attorneys: Andrew T. Tutt (Arnold and Porter Kaye Scholder LLP) for American College of Obstetricians & Gynecologists, Council of University Chairs of Obstetrics and Gynecology, New York State Academy of Family Physicians, Sistersong Women of Color Reproductive Justice Collective and Honor MacNaughton M.D. Hilary Keith Perkins, U.S. Department of Justice, for United States Food and Drug Administration, Stephan Hahn M.D., United States Department of Health and Human Services and Alex Azar J.D.
Companies: American College of Obstetricians & Gynecologists; Council of University Chairs of Obstetrics and Gynecology; New York State Academy of Family Physicians; Sistersong Women of Color Reproductive Justice Collective; United States Food and Drug Administration; United States Department of Health and Human Services
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